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product, the development of process analysis technology (PAT) has emerged as a
method for strategically planning, evaluating, and controlling manufacturing. PAT
involves the timely measurement (i.e., during processing) of crucial quality and
performance attributes related to both raw and in process materials and processes
(Zhang etal. 2020).
In PAT, the word “analysis” is widely understood to refer to combined chemical,
physical, and biological properties (Ramakrishnan etal. 2020). Nonetheless, the
majority of pharmaceutical manufacturing quality control methods concentrate on
physicochemical property analysis. Since natural products are intricate mixtures, it
is extremely difcult for existing chromatographic and spectroscopic methods that
rely on the chemical approach to identify every component of these complicated
mixtures due to their chemical complexity. Moreover, the absence of empirical support for the correlation between the chemical information provided by the chemical
approach and overall invivo activity raises concerns about the clinical safety and
efcacy of medications. Chromatographic procedures, limited by their inability to
detect certain substances, especially certain biologically active components and
bio-pollutants, contribute to the insufciency of available data. The quality of synthetic medications and natural items has been regulated through the application of
biotechnology. Biotechnological techniques offer the advantage of furnishing
insights into the immediate bioactivity, clinical safety, and efcacy of biological
products, notwithstanding their inability to furnish information pertaining to chemical components.
G. Dey et al.
3.3 Monitoring ofProcess
3.3.1 Chemical andBiological Coupling
forPharmaceutical Process
Few bioassays now available can meet the three assay requirements of speed, sensitivity, and multiplexing. Given the multi-component and multi-target nature of natural products, detection strategies with multiplexing capabilities are highly prized.
Consequently, scholars are exploring the integration of biological assays with
chemical analysis. This amalgamation facilitates concurrent examinations of both
biological and chemical aspects on a unied analytical platform, thereby decreasing
instrument costs and variations. Recent developments in ambient ionization technology have made mass spectrometry (MS) a potentially inventive PAT tool in the production of natural products. Li and colleagues (Ramakrishnan etal. 2020) introduced
an on- demand technique utilizing direct analysis in real-time mass spectrometry
(DART-MS). This method assesses the biological activity of specic entities, namely
thrombin and angiotensin-converting enzyme (ACE), employing a mass spectrometry probe as the substrate for the enzymes. Each probe has a distinct peptide sequence
and a high-ionization-efciency label made of 1-(2-pyrimidyl) piperazine. The
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methodology prociently achieved the concurrent evaluation of the chemical composition and biological attributes of Danshen (Salvia miltiorrhiza) injection. The results
from the detection process illustrated the capability of the platform to assess the quality of the drug across various dimensions, all under continuous real-time monitoring.
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3.3.2 Quality Control forPharmaceutical Process by Using
Biological Soft Sensing
Because natural goods are diverse, there is variation in the raw materials and pharmaceutical products, which raises questions about the therapeutic consistency of these
items. For this reason, multi-dimensional quality control is necessary to guarantee
the security and effectiveness of these pharmaceutical items. In addition to being
expensive, using various instruments for the quality analysis of various dimensions
leads to differences between the equipment. A recent and well-liked technique in the
monitoring industry is soft sensing. Thanks to this technology, it is possible to estimate a quality or activity in real time using a mathematical model and readily observable indications that are challenging to measure directly (Fraser et al. 2013).
Consequently, soft sensing performs well when it comes to identifying quality indicators that are challenging to assess in industrial and pharmaceutical operations.
Using the Shuxuening injection as an example, Zhong etal. (Li etal. 2019) employed
a non-destructive method of simultaneously monitoring the injection’s physical characteristics, chemical makeup, and biological activity by combining articial intelligence (AI) with hyperspectral imaging (HSI) as a biological soft sensing technology.
Drug component identication frequently necessitates the use of analytical tools like
high-performance liquid chromatography (HPLC). Z-Gly- GlyArg-AMC acetate
probe substrate and the DPPH-free radical scavenging assay are needed for antioxidant and anticoagulant actions. Image recognition methods are used to identify the
injection’s chromaticity and visible particles. The ve quality indicators of total
ginkgolides, total avonol, anticoagulant activity, antioxidant activity, and visible
particles were predicted by the HSI-AI technique. As a result, the platform may be
utilized to monitor several quality attributes during the production process of pharmaceuticals. Under non-destructive circumstances, biological soft sensing methods
in conjunction with HSI can simultaneously acquire many quality aspects of a sample.
3.4 Intermediate Product Analysis
Variations in natural products and the shifting of operational parameters in each
process unit can cause variations in intermediate quality between batches in the
pharmaceutical process, which can impact the quality of the nished product.
Thus, quality control must be applied to the intermediates generated during the
process.
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G. Dey et al.
3.4.1 Intermediate Product Analysis by Biological
andChemical Coupling
Uncertainty surrounds pharmaceutical items due to the variety of natural product
sources and industrial settings. Every biological and chemical active ingredient that
could have an impact on the potency and quality of medications is precisely and
thoroughly identied. Shuxuening injection (SI) is primarily based on its antioxidant properties. To guarantee its quality, it is crucial to conduct both quantitative
and qualitative evaluations of antioxidants in the pharmaceutical process. An online
analytical approach called ABTSÍ (2,2-azinobis-(3-ethyl benzothiazoline-6- sulfonic
acid))-CE was developed by Ma etal. (Li etal. 2019) to monitor different antioxidants during the injection preparation process. Initially, ABTSÍ was incorporated
into the capillary and utilized for the concurrent identication and segregation of the
primary antioxidants in the injection. The technique is a straightforward, dependable, and efcient instrument for the quantitative assessment of medications, as
demonstrated by the experimental results, which SI validated. Certain indicators are
unable to thoroughly assess TCM compositions with several components, hence
ignoring the chemical complexity and several mechanisms that contribute to their
pharmacological action. Wang etal. (Zhu etal. 2020) suggested a method for evaluating the quality of Typha orientalis by combining metabolomics and chemometrics
with bioactive chemical comprehensive indicators based on thrombin. This study
offers suggestions for developing techniques to assess a drug’s chemical and biological qualities at the same time. This study offers suggestions for developing techniques to assess a drug’s chemical and biological qualities at the same time
(Table3.1) (Fig.3.3).
3.4.2 Biosensors fortheAnalysis ofIntermediate Products
Small, integrated analytical devices known as biosensors are made up of biological
elements in close proximity to physical sensors, which translate biological processes
into quantiable data. Through the utilization of biometric elements that transform
data derived from the biological domain into chemical or physical signals, these sensors furnish precise quantitative or semi-quantitative analytical information (Zhu
etal. 2020; Ma etal. 2018; Wang etal. 2020). In a research endeavor, the identication of bromocriptine was accomplished utilizing a label-free biosensor founded on
surface plasmon resonance (SPR) technology (Andryukov etal. 2021). To ensure the
precision and dependability of the ndings, potential enzymes for the bromocriptine
biosensor were rst evaluated using a competitive inhibition experiment and a protein ligand docking simulation. Drug monitoring that is quick, real time, and labelfree is possible with this enzyme SPR technique. The ndings demonstrated that
different enzymes and SPR technology might be used to monitor different medications. An alternative investigation proposed the utilization of hollow ber-based
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Table 3.1 Application of biotechnology in pharmaceutical manufacturing control
Category Technique Response Applications References
Biosensor for
PAT
Protein chip
for target
enzyme
Biological
chemical
coupling
technology
Biological soft
sensing
technology
HF-AS Lipase-binding
ligand
Enzyme-based
SPR
TPE uorescent
probe
Aptamer
biosensor
FRET
uorescent
acceptor
PAD Hypoglycemic and
Dual channel
microuidic
chip
ABTS+ CE Major antioxidant
Metabolomics
chemometrics
DART-MS
enzyme
NIR machine
learning
HIS-AI-CNN Physical chemical
Acceptable
therapeutic
monitoring
Monitor ACE
activity
Rapid detection of
pathogenic E. coli
Zearalenone and
Partulin
xanthine oxidase
inhibitory activity
Multiple biomarker
assay
in injection
Bioactive chemical
quality marker
combination
Chemical
component and
biological activities
Chemical
compounds and
anti-inammatory
activity
and biological
properties
Lotus leaf extracts Li etal. (2019)
Bromocriptine Ma etal. (2018)
Tongmaiyangxin pill Wang etal.
(2020)
Licorice extracts Jabbari etal.
(2017)
Extracts of TCM Tao etal. (2013)
Mulberry, lotus, and
salvia miltiorrhiza
extracts
Qishen Yiqi pill Gong etal.
Shuxuening
injection
Pollen of T.
orientalis
Danshen injection Li etal. (2017)
Chrysanthemum
extracts
Shuxuening
injection
Wang etal.
(2014), Zhang
etal. (2022),
Zhao etal.
(2018)
(2021)
Guo etal. (2018)
Guo etal. (2019)
Zhong etal.
(2022)
Ding etal.
(2016)
37
afnity selection for identifying inhibitors within a medicinal plant extract
(Bhavadharini etal. 2022). The initial step involved the adsorption of swine pancreas
lipase onto the polypropylene hollow ber surface to establish a resilient ligandharvesting matrix. The known lipase was then used to optimize a number of binding
capacity-related parameters, such as temperature, incubation duration, and enzyme
concentration. Lotus leaf extracts containing lipase-binding ligands can be identied
using the suggested technique. Tetraphenylethylene (TPE) is a common aggregationinduced emission-based uorophore with a variety of uses in cell imaging and biosensors. TPE-based uorescent probes were produced by Wang et al. (Vigneshvar
etal. 2016) using two procedures. Two types of TPE were produced using normal
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Fig. 3.3 Biotechnologies in pharmaceutical manufacturing process control and intermediate
analysis
G. Dey et al.
solid-phase synthesis and the McMurray reaction: TPE with the carboxylate group
and TPE-SDKP.This assay functions as a method for monitoring angiotensin-converting enzyme (ACE) activity and assessing the effectiveness of ACE inhibitors
sourced from extracts. Aptamers, single-stranded oligonucleotide molecules chosen
through ligand evolution using an exponential enrichment mechanism, present
numerous benets, including notable specicity, robust stability, cost-effectiveness,
ease of modication, and straightforward invitro production. They present a viable
alternative to the expensive antibody-based Enzyme-Linked Immunosorbent Assay
(ELISA) and can serve as an alternative recognition element in biosensors alongside
antibodies. Various sensing platforms utilizing aptamers have been developed for the
detection of pollutants and cytotoxins in both food and pharmaceutical contexts.
Cytotoxin and other contaminants have a signicant negative impact on human
health; hence their detection in the pharmaceutical process must be constantly monitored (Jabbari etal. 2017; Tao etal. 2013; Wang etal. 2014; Ahmadi etal. 2019;
Caglayan and U¨stu¨ndag 2020; He etal. 2020; Jiang etal. 2020; Khan etal. 2018).
In a recent study, patulin (PAT) and zearalenone (ZEN) were detected simultaneously
by the use of uorescent acceptors. In this work, uorescent probes tagged FAM and
CY3 on the aptamers of PAT and ZEN, respectively (Khan etal. 2020). Through pep
stacking, both aptamers were adsorbed on the surface of graphene oxide (GO), causing an energy transfer known as uorescence resonance between the uorophore and
GO.As a result, our detection platform detects TCM samples with good selectivity
and reliability. The harm that pathogenic E. coli does to human health is becoming
more and more noticeable (Mahmoud et al. 2019). In a recent study, pathogenic
E. coli was quickly identied using licorice extracts and an aptamer-based electrochemical biosensor. E. coli was biotinylated after the sulfuration signal was initially
detected in order to improve the interaction between the aptamer and the bacteria
(Wu etal. 2018). When E. coli was present, a part of the biotinylated aptamer separated from the capture probe. Streptavidin-alkaline phosphatase was quantitatively
bound by residual biotinylated aptamer probes. The outcomes demonstrated that bacteria in TCM and related disciplines can be quickly detected using the biosensor that
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was designed. The benets of biosensors include excellent accuracy, quick analysis
times, and strong specicity. The integration of computers and biosensors enables
the automated collection and processing of data, leading to more accurate and scientically robust outcomes and the establishment of automated detection systems. To
fully harness the potential of integrated detection systems, there is a growing trend
toward simultaneous coupling of chip technology and sensors.
39
3.4.3 Protein Chips inIntermediate Product Analysis
Paper-based microarrays are paper-based analytical instruments that have seen tremendous development in the last few years (Xing etal. 2020; Zhang etal. 2019,
2022; Zhao etal. 2018). They are inexpensive, simple to use, and capable of carry-
ing out several chemical analyses. Furthermore, the high specic surface area of
these paper devices makes it simple for molecules to bind and adsorb proteins. To
lessen the pollution that experimental consumables produce, used paper devices can
be burned. An excellent background signal for detecting colorimetric reactions is
provided by the white paper. Paper-based microarrays are a type of analytical tool
that have seen fast development in the last few years (Xing etal. 2020; Zhang etal.
2019, 2022; Zhao etal. 2018). They are inexpensive, simple to use, and capable of
carrying out several chemical analyses. Furthermore, the high specic surface area
of these paper devices facilitates easy protein adsorption and binding by molecules.
To lessen the pollution that experimental consumables produce, used paper devices
can be burned. An excellent background signal for detecting colorimetric reactions
is provided by the white paper. In order to build paper-based microarrays and use
them to identify active ingredients in TCM extracts, Gong etal. (Wang etal. 2019).
presented an efcient omics method. Using 3D printing (3DP), customized paper
containing polycaprolactone and chitosan was created, and a-glucosidase was rendered immobile on it. Using a paper-based analytical apparatus, the method was
applied to investigate the hypoglycemic biological activity of lotus and mulberry
extracts (PAD) (Gu etal. 2011; He etal. 2015). Another researcher examined the
xanthine oxidase inhibitory activity of S. miltiorrhiza extracts after immobilizing
xanthine oxidase on a PAD69. Therefore, natural products, intermediates, and preparations can be quickly tested for quality using paper-based microarrays (Mitchell
etal. 2015). Biomarkers have been utilized as evaluative indicators of pharmaceutical quality, serving to appraise the biological attributes of formulations. A good
biomarker should be clinically meaningful and should represent the drug’s mode of
action. In one study, ACEs and thrombin were used as quality biomarkers in a chipbased approach to assess the bio-consistency of natural products. For bioassays, a
dual channel microuidic chip was created (Ahmed etal. 2016), in which an enzymatic reaction takes place in one channel after the creation of an enzyme complex
in the other. In addition to providing an effective surface for immobilizing enzymes,
magnetic beads also act as a dependable, robust base for improved on-chip mixing
and transport. Drug quality (or potency) is indicated by enzyme activity. Several
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batches of intermediates and preparations were evaluated in Qishen Yiqi Pills, and
the ndings indicated that the bioassay outperformed chromatographic ngerprinting in terms of discriminatory power for aberrant samples.
G. Dey et al.
3.4.4 Intermediate Product Analysis Through Biological
Soft Sensing
Although the correlation between spectrum and activity has often been disregarded,
a predominant focus of research has been on elucidating the interconnection
between chromatography/mass spectrometry and the biological activity of natural
products. Using near-infrared reectance spectroscopy (NIRS), chrysanthemum
extracts’ anti-inammatory properties were discovered (Gong etal. 2021). NIRS
was employed in this study together with information on anti-inammatory activity.
Through the utilization of the backpropagation articial neural network, a sophisticated correlation between Q-markers and the overall anti-inammatory efcacy has
been established. In the context of drug quality control, the comprehensive nearinfrared spectroscopy (NIRS) methodology can effectively quantify diverse components and predict the overall biological activity. However, the prediction cannot be
made solely by network toxicology or even bioinformatics, and additional tests are
needed to conrm the ndings.
3.5 Conclusion
Due to their capacity to furnish insights into biological activity, clinical efcacy,
and safety proles of pharmaceuticals, biotechnological methodologies hold comparable importance to techniques reliant on physical and chemical analyses.
In certain situations, botanicals with similar chemical spectra may exhibit different biological activities when the bioactive constituents remain undetectable under
specic analytical conditions. Conversely, botanicals with distinct chemical proles
may demonstrate comparable bioactivity if the phytochemicals responsible for the
variation are biologically inert. These are just some of the advantages and disadvantages of chemical technology and biotechnology. In the future, biotechnology
should be involved in every stage of the drug quality control process, in addition to
chemical and physical investigations. Currently, synthetic and natural products
receive less use of bioanalytical technologies than biological medications. This
could be as a result of the fact that most scientists working in the eld of pharmaceutical analysis have backgrounds in chemistry. Pharmaceutical analysis today
ignores the value of bioassays and their applications. As basic biology continues to
advance and bioanalytical techniques improve as a result, biotechnology can
become increasingly important in the overall quality control of both synthetic and
natural pharmaceuticals.
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41
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Chapter 4
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Applications ofBiotechnology
inPharmaceutical Product Analysis
MohdAslam, AnjaliRani, JavedKhan, BhaskaraNandPant,
andGarimaPandey
Abstract The pharmaceutical sector is critical to supplying safe and effective phar-
maceuticals to people all around the world. Pharmaceutical product efcacy, safety,
and quality are critical, needing stringent analytical methods to assure compliance
with regulatory criteria. With its creative and adaptable approaches, biotechnology
has revolutionized pharmaceutical product analysis by providing enhanced tools for
a reliable and thorough evaluation. This chapter examines the various applications
of biotechnology in pharmaceutical product analysis, focusing on how it has
improved the identication, quantication, and characterization of active pharmaceutical ingredients, contaminants, and formulation components. DNA sequencing,
proteomics, genomics, and bioinformatics techniques have allowed for the exact
determination of constituents as well as the evaluation of their sources. Overall, the
introduction of biotechnology to pharmaceutical product analysis has considerably
improved the pharmaceutical sector’s capacity to ensure reliability, safety, and functionality, instilling greater trust in healthcare practitioners and patients alike.
Keywords Biotechnology · Pharmaceutical analysis · Drug development ·
Biosensors
M. Aslam · A. Rani · J. Khan
Department of Chemistry, SRM Institute of Science and Technology, Delhi-NCR Campus,
Modinagar, Ghaziabad, Uttar Pradesh, India
Department of Chemistry, Atma Ram Sanatan Dharma College, University of Delhi,
New Delhi, India
B. N. Pant
Department of Chemistry, Atma Ram Sanatan Dharma College, University of Delhi,
New Delhi, India
G. Pandey (*)
Department of Chemistry, SRM Institute of Science and Technology, Delhi-NCR Campus,
Modinagar, Ghaziabad, Uttar Pradesh, India
Ltd. 2024
S. Bose et al. (eds.), Concepts in Pharmaceutical Biotechnology and Drug
Development, Interdisciplinary Biotechnological Advances,
https://doi.org/10.1007/978-981-97-1148-2_4
43© The Author(s), under exclusive license to Springer Nature Singapore Pte
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